Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer (NEFERTT)
This study is ongoing, but not recruiting participants.
Sponsor:
Puma Biotechnology, Inc.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00915018
First received: June 4, 2009
Last updated: May 7, 2012
Last verified: May 2012
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Purpose
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Advanced Breast Cancer |
Drug: Neratinib + Paclitaxel Drug: Trastuzumab + Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Puma Biotechnology, Inc.:
Primary Outcome Measures:
- Progression-Free Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 43 months ] [ Designated as safety issue: No ]
- Objective Response Rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: 31 months ] [ Designated as safety issue: No ]
- Clinical Benefit Rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
- Incidence of Adverse Events between treatment arms [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]
- Patient Reported Breast Specific Quality of Life [ Time Frame: 31 months ] [ Designated as safety issue: No ]
- Frequency of symptomatic or progressive CNS lesions [ Time Frame: 31 months ] [ Designated as safety issue: No ]
- Time to symptomatic or progressive CNS lesions [ Time Frame: 31 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 480 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Neratinib + Paclitaxel
|
Drug: Neratinib + Paclitaxel
Neratinib - 240 mg orally daily, administered once daily Paclitaxel - 80mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. |
|
Active Comparator: 2
Trastuzumab + Paclitaxel
|
Drug: Trastuzumab + Paclitaxel
Trastuzumab - 4mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Paclitaxel - 80mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
Exclusion Criteria:
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- history of heart disease
- history of gastrointestinal disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915018
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| United States, California | |
| Pfizer Investigational Site | |
| Oxnard, California, United States, 93030 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Britain, Connecticut, United States, 06052 | |
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| Southington, Connecticut, United States, 06489 | |
| United States, Florida | |
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| Boynton Beach, Florida, United States, 33435 | |
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| Deerfield Beach, Florida, United States, 33064 | |
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| Fort Lauderdale, Florida, United States, 33308 | |
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| Fort Lauderdale, Florida, United States, 33316 | |
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| Orange City, Florida, United States, 32763 | |
| United States, Georgia | |
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| Albany, Georgia, United States, 31701 | |
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| Dublin, Georgia, United States, 31021 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60611 | |
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| Highland Park, Illinois, United States, 60035 | |
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| Skokie, Illinois, United States, 60077 | |
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| Skokie, Illinois, United States, 60076 | |
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| Springfield, Illinois, United States, 62703 | |
| United States, Louisiana | |
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| Alexandria, Louisiana, United States, 71301 | |
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| Marrero, Louisiana, United States, 70072 | |
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| Metairie, Louisiana, United States, 70006 | |
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| New Orleans, Louisiana, United States, 70115 | |
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| St Louis Park, Minnesota, United States, 55426 | |
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| St. Louis Park, Minnesota, United States, 55426 | |
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| Branson, Missouri, United States, 65616 | |
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| Columbia, Missouri, United States, 65201 | |
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| Nixa, Missouri, United States, 65714 | |
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| Springfield, Missouri, United States, 65804 | |
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| Springfield, Missouri, United States, 65807 | |
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| St Louis, Missouri, United States, 63110 | |
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| St. Louis, Missouri, United States, 63141 | |
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| St. Louis, Missouri, United States, 631110 | |
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| St. Louis, Missouri, United States, 63110 | |
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| St. Peters, Missouri, United States, 63376 | |
| United States, New Jersey | |
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| Paramus, New Jersey, United States, 07652 | |
| United States, North Carolina | |
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| Gastonia, North Carolina, United States, 28054 | |
| United States, Ohio | |
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| Akron, Ohio, United States, 44304-1619 | |
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| Tulsa, Oklahoma, United States, 74104 | |
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| Corvallis, Oregon, United States, 97330 | |
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| Pawtucket, Rhode Island, United States, 02860 | |
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| Charleston, South Carolina, United States, 29425 | |
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| Mt. Pleasant, South Carolina, United States, 19464 | |
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| Sumter, South Carolina, United States, 29150 | |
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| Knoxville, Tennessee, United States, 37909 | |
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| Memphis, Tennessee, United States, 38119 | |
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| Memphis, Tennessee, United States, 38120 | |
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| Bedford, Texas, United States, 76022 | |
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| El Paso, Texas, United States, 79912 | |
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| Fort Worth, Texas, United States, 76177 | |
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| Midland, Texas, United States, 79701 | |
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| Salt Lake City, Utah, United States, 84106 | |
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| Charleston, West Virginia, United States, 25304 | |
| Australia, South Australia | |
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| Parkville, Victoria, Australia, 3050 | |
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| Lesnoy, Minsk region, Belarus, 223040 | |
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| Gomel, Belarus, 246012 | |
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| Grodno, Belarus, 230017 | |
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| Vitebsk, Belarus, 210603 | |
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| Brussels, Belgium, 1000 | |
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| Plovdiv, Bulgaria, 4004 | |
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| Sofia, Bulgaria, 1756 | |
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| Sofia, Bulgaria, 1233 | |
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| Greenfield Park, Quebec, Canada, J4V 2H1 | |
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| Trois-Rivieres, Quebec, Canada, G8Z 3R9 | |
| China, Beijing | |
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| Beijing, Beijing, China, 100071 | |
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| Beijing, Beijing, China, 100853 | |
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| Beijing, Beijing, China, 100730 | |
| China, Guangdong | |
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| Guangzhou, Guangdong, China, 510515 | |
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| Guangzhou, Guangdong, China, 510060 | |
| China, Tian Jin | |
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| Tian Jin, Tian Jin, China, 300060 | |
| China, Zhejiang | |
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| Hangzhou, Zhejiang, China, 310022 | |
| China | |
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| Beijing, China, 100853 | |
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| Beijing, China, 100021 | |
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| Shanghai, China, 200032 | |
| Croatia | |
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| Osijek, Croatia, 31000 | |
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| Zagreb, Croatia, 10000 | |
| Denmark | |
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| Copenhagen, Denmark, 2100 | |
| France | |
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| Lyon, France, 69373 | |
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| Paris, France, 75181 | |
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| Paris, France, 75674 | |
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| Paris cedex 13, France, 75651 | |
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| Perigueux, France, 24000 | |
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| St Brieuc, France, 22015 | |
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| Strasbourg, France, 67000 | |
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| Strasbourg, France, 67091 | |
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| Tours, France, 37044 | |
| Germany | |
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| Bamberg, Germany, 96049 | |
| Hong Kong | |
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| Hong Kong, Hong Kong | |
| Hungary | |
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| Budapest, Hungary, 1122 | |
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| Budapest, Hungary, 1115 | |
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| Budapest, Hungary, 1082 | |
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| Kaposvar, Hungary, 7400 | |
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| Kecskemet, Hungary, 6000 | |
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| Miskolc, Hungary, 3526 | |
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| Szeged, Hungary, 6720 | |
| India | |
| Pfizer Investigational Site | |
| Bhopal, Madhya Pradesh, India, 462001 | |
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| Mumbai, Maharashtra, India, 400012 | |
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| Nagpur, Maharashtra, India, 440010 | |
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| Nashik, Maharashtra, India, 422004 | |
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| Nashilk, Maharashtra, India, 422002 | |
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| Pune, Maharashtra, India, 411004 | |
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| Jaipur, Rajasthan, India, 302013 | |
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| Madurai, Tamil Nadu, India, 625107 | |
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| Kolkata, West Bengal, India, 700053 | |
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| New Delhi, India, 110029 | |
| Israel | |
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| Rehovot, Israel, 76101 | |
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| Tel Aviv, Israel, 64239 | |
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| Zerifin, Israel, 60930 | |
| Italy | |
| Pfizer Investigational Site | |
| Modena, Italy, 41100 | |
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| Pavia, Italy, 27100 | |
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| Roma, Italy, 00189 | |
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| Roma, Italy, 00128 | |
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| Torino, Italy, 10126 | |
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| Aichi, Japan | |
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| Chiba, Japan | |
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| Hiroshima, Japan | |
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| Osaka, Japan | |
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| Tochigi, Japan | |
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| Tokyo, Japan | |
| Korea, Republic of | |
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| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
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| Seoul, Korea, Korea, Republic of, 138-736 | |
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| Seoul, Korea, Korea, Republic of, 152-703 | |
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| Seoul, Korea, Korea, Republic of, 135-710 | |
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| Seoul, Seoul/Korea, Korea, Republic of, 120-752 | |
| Latvia | |
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| Liepaja, Latvia, LV-3401 | |
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| Riga, Latvia, LV-1079 | |
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| Riga, Latvia, LV - 1002 | |
| Lithuania | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, LT-50009 | |
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| Kaunas, Lithuania, LT 44307 | |
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| Vilnius, Lithuania, LT-08660 | |
| Malaysia | |
| Pfizer Investigational Site | |
| Kuala Lumpur, Malaysia, 59100 | |
| Malta | |
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| Floriana, Malta, VLT 14 | |
| Poland | |
| Pfizer Investigational Site | |
| Bialystok, Poland, 15027 | |
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| Jelenia Gora, Poland, 58-506 | |
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| Olsztyn, Poland, 10228 | |
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| Opole, Poland, 45060 | |
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| Warszawa, Poland, 04125 | |
| Portugal | |
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| Lisboa, Portugal, 1500-650 | |
| Romania | |
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| Cluj-Napoca, Cluj, Romania, 400015 | |
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| Craiova, Dolj, Romania, 200385 | |
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| Bucuresti, Romania, 050098 | |
| Serbia | |
| Pfizer Investigational Site | |
| Belgrade, Serbia, 11000 | |
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| Nis, Serbia, 18000 | |
| Singapore | |
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| Singapore, Singapore, 169610 | |
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| Singapore, Singapore, 119074 | |
| South Africa | |
| Pfizer Investigational Site | |
| Port Elizabeth, Eastern Cape, South Africa, 6045 | |
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| Johannesburg, Gauteng, South Africa, 2196 | |
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| Johannesburg, Gauteng, South Africa, 2193 | |
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| Johannesburg, Gauteng, South Africa, 2199 | |
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| Pretoria, Gauteng, South Africa, 0081 | |
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| Durban, KwaZulu Natal, South Africa, 4001 | |
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| Kraaifontein, Western Cape, South Africa | |
| Spain | |
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| Santiago de Compostela, A Coruna, Spain, 15706 | |
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| Alcorcon, Madrid, Spain, 28922 | |
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| Majadahonda, Madrid, Spain, 28222 | |
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| Parla, Madrid, Spain, 28981 | |
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| Sanchinarro, Madrid, Spain, 28050 | |
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| Marbella, Malaga, Spain, 29603 | |
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| Baracaldo, Vizcaya, Spain, 48903 | |
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| Lleida, Spain, 25198 | |
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| Madrid, Spain, 28041 | |
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| Madrid, Spain, 28034 | |
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| Madrid, Spain, 28033 | |
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| Palma de Mallorca, Spain, 07198 | |
| Switzerland | |
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| Aarau, Switzerland, 5000 | |
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| Thun, Switzerland, 3600 | |
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| Winterthur, Switzerland, 8401 | |
| Taiwan | |
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| Taoyuan, Taiwan, 333 | |
| Turkey | |
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| Bornova/Izmir, Turkey, 35100 | |
| Ukraine | |
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| Cherkassy, Ukraine, 18009 | |
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| Chernivtsi, Ukraine, 58013 | |
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| Dnipropetrovsk, Ukraine, 49102 | |
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| Donetsk, Ukraine, 83092 | |
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| Kharkiv, Ukraine, 61024 | |
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| Kyiv, Ukraine, 03022 | |
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| Lutsk, Ukraine, 63000 | |
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| Lviv, Ukraine, 79031 | |
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| Mariupil, Ukraine, 87500 | |
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| Sumy, Ukraine, 40005 | |
| United Kingdom | |
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| London, United Kingdom, SE1 9RT | |
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| Nottingham, United Kingdom, NG5 1PB | |
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
| Study Director: | Puma | Biotechnology |
More Information
No publications provided
| Responsible Party: | Puma Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00915018 History of Changes |
| Other Study ID Numbers: | 3144A2-3005, B1891005 |
| Study First Received: | June 4, 2009 |
| Last Updated: | May 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Trastuzumab Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013